During the 2000’s, preclinical research studies began to find that laboratory animals exposed to commonly used anesthetic and sedative drugs early in life showed changes to the brain and nervous system that interfered with memory and learning. Additional research during this time set off alarms for the Food and Drug Administration (FDA), parents, and the anesthesia practitioner community. The FDA held its first Advisory Committee hearing on this issue in 2007. As an outcome of that meeting, representatives from the FDA reached out to the International Anesthesia Research Society (IARS) in 2008 with the idea of forming a Public Private Partnership to address these new, startling findings. IARS was uniquely positioned to partner with the FDA due to its non-political collaborative mission, infrastructure, expertise and commitment to research, education and advancing the specialty.
The partnership, entitled SmartTots, brought the IARS and FDA together to address this pressing issue for 11 years, through three federal funding cycles. With the goal of addressing scientific and clinical gaps regarding the safe use of anesthetics and sedatives in children, SmartTots actively convened and collaborated with multiple stakeholders, including academic research institutions, medical professionals and societies, and other government and nonprofit organizations. An effective infrastructure was built to provide timely, regular communications with investigators, clinicians, and the public about the impact of ongoing research.
SmartTots quickly became THE resource for up-to-the-minute information about developments in pediatric anesthetic neurotoxicity research. Educational resources include a bimonthly newsletter summarizing the latest research articles, a resource-rich website, downloadable handouts, for professionals and the public, video presentations by researchers in the field, and exhibit booths at professional society meetings. SmartTots also brings together the leading scientists in the field biannually to meet and discuss research progress and direction, an innovative approach in a historically competitive research environment. SmartTots investigators engage collaboratively, acknowledging the importance of teamwork to resolve this issue for the most vulnerable patients. SmartTots also coordinates scientific symposia at major anesthesia meetings, ensuring that the latest findings are shared and debated.
Additionally, SmartTots sponsors publications in leading journals. Recently, a group of investigators in the field published a white paper that summarized the accumulated data from the past 20 years, synthesized the current state of the research, and proposed a path forward. The article, Anesthesia and Developing Brains: Unanswered Questions and Proposed Paths Forward (Ing et al), appeared in the March 2022 issue of Anesthesiology (https://doi.org/10.1097/ALN.0000000000004116).
What SmartTots has accomplished so far:
- Provided $900,000 in funding for pediatric anesthetic neurotoxicity research
- Distributed over 75 newsletters with over 1,100 research article summaries to approximately 1,500 subscribers per edition
- Exhibited at 65+ anesthesiology meetings
- Engaged over 165,000 visitors on the SmartTots website from 75 different countries
- Coordinated 20+ educational sessions, both virtual and live, at the annual meetings of the International Anesthesia Research Society and the American Society of Anesthesiologists.
What is known so far:
- Pre-clinical studies continue to confirm that laboratory animals exposed to most anesthetic and sedative drugs early in life show changes to the brain and nervous system that can interfere with memory, learning, and behavior.
- A single, short general anesthetic exposure is associated with no difference in general intelligence
- Recent, accumulating clinical data in young children suggest alterations in behavior, but not cognition, from single exposures.
- Additional research, including long-term studies in neonates and young children are needed.
SmartTots continues its diligence to address the gaps in research with the goal of making anesthesia and sedation safer for children around the world. To this end, in 2022 IARS awarded $300,000+ in funding to two studies to further address the gaps in knowledge.
As of 2022, the FDA partnership has concluded, but SmartTots and its important mission remains intact through IARS sponsorship. The newsletter, website, exhibit booths, investigator meetings and scientific symposia will continue until a definitive answer is found. Finding an answer will take a great deal of time and money, but IARS’ commitment to SmartTots is steadfast.